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New FDA Warning for Xolair

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Jarod Cassidy3 years ago

The U.S. Food and Drug Administration (FDA) has added a new warning to the asthma drug Xolair addressing an increased risk of heart attack, mini-strokes, and blood clots.

About the Xolair Warning

Xolair (omalizumab) is an injectable drug approved in 2003 for the treatment of asthma in patients over the age of 12 whose asthma is not well-controlled with corticosteroid medications. Approval was later expanded to cover chronic hives as well.

The latest warning follows a five-year study completed by the drug’s manufacturer, Genetech. The FDA also analyzed 25 other clinical trials that assessed Xolair’s efficacy and safety against a placebo.

The FDA states that while their findings suggest a serious safety signal for cardiovascular and cereborvascular events, they were unable to determine the exact cause for these risks.

Other Xolair Side-Effects

The following adverse events have been reported in patients taking Xolair:

  • Anaphylactic reaction
  • Blood pressure increase
  • Dizziness
  • Headache
  • Chest pain
  • Heart rate increase
  • Back pain
  • Swelling of the face
  • Atrial fibrillation
  • Convulsion
  • Death


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